Rehabilitation After Radiotherapy for Prostate Cancer

Phase 2

Completed

• Conditions: Urinary Irritative/Incontinence Problems; Bowel Problems; Sexual Problems; Hormonal Problems; Phycological Problems
• Interventions: Behavioral: RePCa A

• Registration Number: NCT01272648
• Lead Sponsor: Odense University Hospital

Brief Summary

This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.

The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.

Detailed Description

More cancer patients are now being cured or living a long time with the disease. Prostate cancer (PCa) is one of the cancer diseases, where the treatment can give some late side effects and cause reduced life quality.

This project will as a part of a ph.d. study, test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project is consisted of a randomised controlled test of the intervention and qualitative evaluation.

More and more Danish men are diagnosed with PC, the incidence increased with 34 percent from 2005-2007. This is caused partly due to a change in the age in the society and due to earlier diagnostics. PCa is now the most known cancer occurring in men in Denmark.

If the disease has not yet been metastasized, it is possible to use radiotherapy often in combination with anti hormones. It is possible to cure the patient, íf his disease is discovered in time, but there are some late side effects bond to the treatment, and they have influence of the patients quality of life. These are: impotence, incontinence, problem with the bowels, anxiety and depression.

The project is as followed:

Rehabilitation: Examine if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer. The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.

Methods: Prospective randomised controlled study. Material: 160 patients are included. 80 patients in the intervention group and 80 patients in the control group.

Study Timeline

• Study Start: 2010-02
• Status Verified: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 161

Inclusion Criteria

• Patients with localized og locally advanced prostate cancer treated with curative intended radiotherapy at Department of Oncology Odense University Hospital in the period of inclusion

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Exclusion Criteria

• Patients younger than 18
• Patients who cannot understand/read or speak danish

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation	RePCa A	note intervention
Control	RePCa A	same radiotherapy but no rehabilitation

Primary Outcome Measures

Name	Time	Method
HRQOL urinary irritative score	12 month	The expanded prostate cancer Index Composite (EPIC)irritative score

Secondary Outcome Measures

Name	Time	Method
EMG measurement of pelvic floor muscles	12 month	Strength of pelvic floor muscles measured with electromyography

Trial Locations

Locations (1)

Department of Oncology Odense University Hospital; 🇩🇰 Odense, Denmark